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Edge Therapeutics, Inc.

26 days left to seek lead plaintiff status

Case Summary

Company Name
Edge Therapeutics, Inc.
Stock Symbol
Class Period
December 29, 2017 to March 27, 2018
Motion Deadline
June 22, 2018
District of New Jersey

The complaint charges Edge and certain of its officers with violations of the Securities Exchange Act of 1934.  Edge operates as a clinical-stage biotechnology company that discovers, develops and commercializes hospital-based therapies for the management of acute, life-threatening neurological conditions.  Edge’s lead product candidate is EG-1962.  During the Class Period, the Company was conducting its Phase 3 NEWTON 2 study of EG-1962 for the treatment of patients with aneurysmal subarachnoid hemorrhage, or aSAH, which occurs when a brain aneurysm ruptures, causing bleeding into the compartment surrounding the brain.

The complaint alleges that throughout the Class Period, defendants misrepresented and/or concealed material information regarding the Company’s business, operations and prospects.  Specifically, despite claims that Edge had “achieved meaningful progress as [it] continued to develop and [sought] to commercialize EG-1962 to address the unmet need of patients with . . . aSAH,” and that Edge was “operationally and financially well-positioned to execute [its] corporate growth strategy” by “continuing to advance EG-1962 through achievement of key additional clinical milestones,” defendants failed to disclose that EG-1962 would likely fail a futility analysis in connection with the Phase 3 NEWTON 2 study.  As a result of defendants’ misrepresentations and/or omissions, the price of Edge common stock was artificially inflated to a high of $17.47 per share during the Class Period.

Then on March 28, 2018, Edge disclosed “that a pre-specified interim analysis on data from the Day 90 visit of the first 210 subjects randomized and treated in the Phase 3 NEWTON 2 study of EG-1962 demonstrated a low probability of achieving a statistically-significant difference compared to the standard of care in the study's primary endpoint, if the study is fully enrolled.”  As a result, the Data Monitoring Committee (“DMC”) “recommended that the study be stopped based on its conclusion that the study has a low probability of meeting its primary endpoint.”  Based on the DMC’s recommendation, Edge stated it had decided to discontinue the Phase 3 NEWTON 2 study on EG-1962.  On this news, the price of Edge common stock fell $14.28 per share, or nearly 92%, to close at $1.31 per share on March 28, 2018.

Class Period: December 29, 2017 - March 27, 2018
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